Thopaz ™
Current Research Findings
PROVIDING ADVANCED TREATMENT WITH EASE
Precious life – Progressive care
Thoracic Drainage System
Index
Multicenter International Randomized Comparison of Objective and Subjective
Outcomes Between Electronic and Traditional Chest Drainage Systems........................... C. Pompili, F. Detterbeck, K. Papagiannopoulos, A. Sihoe, K. Vachlas, M. W. Maxfield,
H. C. Lim, A. Brunelli.
The Annals of Thoracic Surgery. (2014) 98: 490–497.
Page
4
Does External Pleural Suction Reduce Prolonged Air Leak After Lung Resection?
Results from the AirINTrial After 500 Randomized Cases................................................... 7
F. Leo, L. Duranti, L. Girelli, S. Furia, A. Billè, G. Garofalo, P. Scanagatta, R. Giovannetti,
U. Pastorino
Annals of Thoracic Surgery. (2013). 96:1234–1239.
Regulated tailored suction vs regulated seal: A prospective randomized trial
on air leak duration.............................................................................................................. 9
A. Brunelli, M. Salai, C. Pompili, M. Refai, A. Sabbatini
European Journal of Cardio-Thoracic Surgery 0 (2012) 1–6.
Impact of the learning curve in the use of a novel electronic chest drainage
system after pulmonary lobectomy: a case-matched analysis on the duration
of chest tube usage.............................................................................................................. 11
C. Pompili, A. Brunelli, M. Salati, M. Refai, A. Sabbatini
Interactive Cardiovascular & Thoracic Surgery. (2011). 13:490–493.
Open access article available online.
Thopaz Portable Suction Systems in Thoracic Surgery:
An end user assessment and feedback in a tertiary unit..................................................... 13
S. Rathinam, A. Bradley, T. Cantlin, P. B. Rajesh
Journal of Cardiothoracic Surgery. (2011) 6:59.
Open access article available online.
The benefits of digital air leak assessment after pulmonary
resection: Prospective and comparative study................................................................... 15
J. M. Mier, L. Molins, J. J. Fibla Cirugía Española. (2010). 87(6):385–389
Postoperative chest tube management: measuring air leak using an electronic
device decreases variability in the clinical practice............................................................ 17
G. Varela, M. F. Jimenez, N. M. Novoa, J. L. Aranda
European Journal of Cardio-thoracic Surgery. (2009). 35:28–31
The quantification of postoperative air leak........................................................................ 19
Cerfolio R. J., Bryant A. S. (2009) Multimedia Manual of Cardiothoracic Surgery.
DOI:10.1510/mmcts.2007.003129.
Multicenter International Randomized Comparison of Objective
and Subjective Outcomes Between Electronic and Traditional
Chest Drainage Systems
4
C. Pompili, F. Detterbeck, K. Papagiannopoulos, A. Sihoe, K. Vachlas, M. W. Maxfield, H. C. Lim,
A. Brunelli. The Annals of Thoracic Surgery. (2014) 98: 490–497
Study Background & Design
The aim of this study was to compare a digital (Thopaz) versus a traditional drainage system with patients who underwent pulmonary lobectomy or segmentectomy for the objective (duration of chest tube
placement) and subjective (patient satisfaction) outcome at 4 international centers (United States, United
Kingdom, Italy and Hong Kong). The study also explored whether differences in expectations or health
care systems in the 4 regions of the world affected the observed differences between these groups. This
study was conducted on patients randomized into two groups (191 digital; 190 traditional) who were well
matched for baseline and surgical characteristics. The digital (Thopaz) group were placed on -20 cmH20
until the morning of postoperative day 1, and then physiological mode (-8 cmH2O) thereafter. Traditional
devices were attached to wall suction (-20 cmH20) until the morning of postoperative day 1, and then
transferred to water seal thereafter. On the digital system, chest tubes were removed when the air flow
was lower than 30 ml/min for 8 hours without spikes of air leak, and on the traditional system when no
detectable air leak was observed. Fluid criteria for drain removal ranged from 300–400 ml/day depending
upon center. Patient satisfaction was assessed through a questionnaire as outlined in Table 1.
Question 1:
Do you feel that your chest drainage system
prevents you from getting out of bed?
1.
2.
3.
4.
5.
I cannot get out of bed.
I can get out of bed infrequently or with great difficulty.
I can get out of bed most of the time but with some limitations.
I can get out of bed with minor inconvenience.
I can get out of bed all the time.
Question 2:
Does your chest drainage system allow you to walk
around the room or ward alone?
1.
2.
3.
4.
5.
I cannot walk freely.
I can walk freely infrequently or with great difficulty.
I can walk freely most of the time but with some limitations.
I can walk freely with minor inconvenience.
I can walk freely all the time.
Question 3:
How convenient or inconvenient for the personnel or
other patients do you think your chest drainage system
is?
1.
2.
3.
4.
5.
Very inconvenient
Inconvenient
Neither convenient or inconvenient
Convenient
Very convenient
1.
Question 4:
How easy to carry around would you consider your chest 2.
3.
drainage system?
4.
5.
Very difficult
Difficult
Neither easy or difficult
Easy
Very easy
Question 5:
How socially comfortable do you feel when walking in
public areas with this device?
1.
2.
3.
4.
5.
Very uncomfortable
Uncomfortable
Neither comfortable or uncomfortable
Comfortable
Very comfortable
Question 7:
How comfortable do you feel at night in your bed with
your chest drainage system (moving in bed, changing
position)?
1.
2.
3.
4.
5.
Very uncomfortable
Uncomfortable
Neither comfortable or uncomfortable
Comfortable
Very comfortable
Table 1: Questionnaire used to assess patient satisfaction of their chest drainage
device using a 5-point Likert-type scale.
Results
The study shows that patients randomized to digital systems had a significantly shorter air leak duration,
duration of chest tube placement and postoperative length of hospital stay (Figure 1) and that this was
consistent across the 4 global centers (Figure 2). Importantly, patients on the digital system experienced
a greater than 50% reduction in the duration of air leak (Figure 1).
6
5
5.6
4.7
4
3
4.6
3.6
2
Digital drainage
device
Traditional
drainage device
2.2
1
0
1.0
Duration air leak
(p=0.001)
Duration chest
tube placement
(p=0.0001)
Postoperative
length of hospital stay
(p <0.0001)
Figure 1: Duration of air leak, chest tube placement and postoperative length of
hospital stay (days).
5
6
5
6
4
3
5.8
5.8
5.4
4.9
4.6
4.9
4.9
3.8
2
Digital
Traditional
1
0
US
UK
Italy
HK
Figure 2: Differences in length of postoperative stay (days) in different centers.
(US=United States; UK=United Kingdom; HK=Hong Kong).
Assessment of patient satisfaction of their chest drainage device showed that patients managed with
digital device had a more positive perception of their chest drainage system, in particular related to its
comfort, portability and convenience for personnel and patients compared with those managed with the
traditional device.
4.0
3.5
3.9
3.7
3.0
3.3
2.5
3.5
3.1
3.3
3.6 3.5
3.2
3
3
2.8
2.0
1.5
Digital
Traditional
1.0
0.5
0.0
Q1
Q2
Q3
Q4
Q5
Q7
Figure 3: Results of the comparison of patient satisfaction between the 2 groups.
Higher scores reflect a more positive perception of the system. (Q=Question).
Conclusions
lPatients managed with Thopaz experienced a greater than 50% reduction in air leak duration, a
shorter duration of chest tube drainage and 1 day reduction in hospital stay when compared with
those managed with traditional devices.
lSubjective outcomes showed higher satisfaction scores for Thopaz with improved ability of patients
to arise from bed and a greater convenience for patients and personnel.
l These findings appeared to be consistent across different health care systems and countries.
Does External Pleural Suction Reduce Prolonged Air Leak
After Lung Resection? Results from the AirINTrial After
500 Randomized Cases
F. Leo, L. Duranti, L. Girelli, S. Furia, A. Billè, G. Garofalo, P. Scanagatta, R. Giovannetti,
U. Pastorino. Annals of Thoracic Surgery. (2013). 96:1234–1239.
Study Background & Design
The aim of this study was to test the hypothesis if external suction may reduce the rate of prolonged air
leak. Portable suction devices, such as Thopaz, became interesting as they record a large amount of data
on airflow and intrapleural pressure, which have been suggested as being predictors of prolonged air
leak. Furthermore, increased mobility due to portable suction may play a role in promoting lung healing.
This study presents results of the first interim analysis after randomization of 500 cases, with 250 in each
of the external suction and no external suction (control) groups.
Results
There was no significant difference (p>0.05) between the two groups in terms of demographic and clinical
characteristics of the population after randomization. On postoperative day 7, the chest drain was still
in place in 25 patients in the external suction group and in 34 patients in no external suction group. The
difference between the two groups was significant (p<0.05) in favor of the external suction group and
in those patients undergoing anatomical compared to non-anatomical resection. The results show that
external s uction reduces the prolonged air leak rate in this subgroup of patients (Figure 1). There was no
significant differences (p>0.05) observed between the two groups in any other post-operative outcomes.
*
25
25
20
15
10
*
14
11
5
9
0
Anatomic
Nonanatomic
Figure 1: Number of patients with Prolonged Air Leak on POD7. Comparison
between the external suction and no external suction (control) groups for both
Anatomic and Nonanatomic resections. *(p<0.05)
External suction
No external suction
7
60
56
40
8
20
35
12
10
9
5
4
External suction
No external suction
4
2
0
Pleural
(p=0.01)
Pneumothorax
(p=0.04)
Subcutaneous
emphysema
(p=0.16)
1
Empyema,
without fistula
(p=0.5)
Figure 2: Number of patients with pleural complications.
Conclusions
l Routine use of external suction reduces the rate of prolonged air leak after anatomic lung resection.
l Use of external suction reduces the rate of pleural complications, specifically pneumothoraces.
Regulated tailored suction vs regulated seal: A prospective
randomized trial on air leak duration
A. Brunelli, M. Salai, C. Pompili, M. Refai, A. Sabbatini
European Journal of Cardio-Thoracic Surgery 0 (2012) 1–6.
9
Study Background & Design
This study was aimed to compare the air leak duration of two regulated chest tube modes following
pulmonary lobectomy by using an electronic regulated suction system. 100 patients with consecutive pulmonary lobectomies performed for lung cancer were included in the trial, group 1 with regulated
individualized suction mode (range: -11 to -20 cmH2O, according to lobectomy type; n=50) and group 2,
with regulated seal mode (-2 cmH2O; n=50). The duration of air leak was the main endpoint calculated
from the end of the operation to a value consistently below 20ml/min.
Results
The two groups were well matched for baseline and surgical characteristics with exception of more males
and lower FEV1/FVC ratio in the regulated seal group. No crossovers occurred between groups. There
was no significant d
ifference (p>0.05) between right side of lobectomy, upper side of lobectomy, pleural
adhesions, length of stapled parenchyma, pleural effusion in first 48h, and percentage of patients with an
air leak at 5 or 7 days.
8
7
6
6.1
5
5.1
4
4.3
3
4.3
2
1
0
1.2
Regulated suction
Regulated seal
0.9
Duration air leak
(p=0.8)
Chest tube duration
(p=0.7)
Length of hospital stay
(p=0.3)
Figure 1: Duration of air leak, chest tube duration and length of hospital stay (days).
10%
10%
10%
8%
8%
10
8%
6%
4%
Air leak >5 days (%) (p=1)
Air leak >7 days (%) (p=1)
2%
0%
Regulated suction
Regulated seal
Figure 2: Percentage of patients with an air leak greater than 5 and 7 days.
500
400
447
483
300
200
Effusion in the first 48 h
(p=0.6)
100
0
Group 1
Regulated suction
(50)
Group 2
Regulated seal
(50)
Figure 3: Amount (ml) of pleural effusion in the first 48 hours.
Conclusions
l Regulated seal mode has the same effect as the regulated suction in managing chest tubes following
lobectomy.
l The study demonstrates with objective data the non-superiority of regulated suction vs regulated seal and may
assist in future studies on regulated pleural pressure.
l The study confirms, under controlled conditions, previous observations about the substantial equivalence
between suction and no suction.
Impact of the learning curve in the use of a novel electronic
chest drainage system after pulmonary lobectomy: a casematched analysis on the duration of chest tube usage.
C. Pompili, A. Brunelli, M. Salati, M. Refai, A. Sabbatini. Interactive Cardiovascular &
Thoracic Surgery. (2011). 13:490-493. Open access article available online.
Study Background & Design
This study aimed to determine the duration of learning Thopaz, when first introduced into a clinical
environment, and the impact it has on chest tube duration, length of stay and hospital costs. Using
propensity score case-matched analysis, the first consecutive 51 lobectomy patients managed with
Thopaz were compared to 51 controls managed with a traditional chest drain. There was no significant
difference in the characteristics of the two matched groups (p > 0.05). In both groups, patients were
placed on -15 cmH2O during the day and whilst sleeping were placed on Water Seal (traditional sytems)
or Gravity Mode (Thopaz). Criteria for removing the drain at -15 cmH2O were as follows: Traditional
systems required an absence of air leak following repeated expiratory efforts, whilst on Thopaz required
a flow of < 40 ml/min, stable on the graph for 8h. On both systems a pleural effusion < 400 ml/24h was
required.
Results
Patients managed with Thopaz had a significantly shorter duration of chest tube drainage (P < 0.0001)
and shorter hospital stay (P < 0.001) when compared to patients on traditional systems (Figure 1).
6
6.0
5
4
4.5
4.4
3
2.5
2
Days of drainage
Days in hospital
1
0
Traditional System
Thopaz
Figure 1: Length of chest drainage and length of hospital stay for patients on
traditional systems compared to Thopaz.
11
The use of Thopaz significantly (P < 0.001) reduced hospital costs by an average of €751 per patient
(Figure 2).
2500
12
€ 751
€ 2’553
2000
1500
€ 1’802
1000
Hospital savings
per patient
Hospital cost
per patient
500
0
Traditional System
Thopaz
Figure 2: Per patient cost and savings associated with using Thopaz.
Benefits of Thopaz were evident from the first patient, however the maximum benefit was achieved
by patient number 40.
3.5
3.0
Days of drainage
for traditional
systems
2.5
Days of drainage
for Thopaz
2.0
10
20
30
40
50
Patients ordered by date of operation
Figure 3: Learning curve of Thopaz, showing that maximum benefit in using Thopaz,
as measured by duration of chest drainage, is achieved after 40 patients.
Conclusions
l Compared with traditional devices, the use of Thopaz was beneficial from its initial application.
l The learning curve was short and did not affect the efficiency of the system.
l Thopaz reduced the duration of chest tube drainage and length of stay thereby significantly reducing
the costs to the hospital.
l Study limitations include prior experience with digital drainage devices in this hospital, and that the
study population included only pulmonary lobectomies.
Thopaz Portable Suction Systems in Thoracic Surgery:
An end user assessment and feedback in a tertiary unit.
S. Rathinam, A. Bradley, T. Cantlin, P. B. Rajesh
Journal of Cardiothoracic Surgery. (2011) 6:59. Open access article available online.
Study Background & Design
Traditional chest drainage has been achieved by connecting the chest drain bottles to wall suction.
However, the negatives include; impaired patient mobility, variable suction applied to the patient, infection
risk, and the assessment of air leak being subjective. Thopaz is a portable chest drain which allows for
mobilization of the patient, and has scientific digital flow recordings with an inbuilt alarm system. After
2.5 months of using Thopaz on 120 patients, 15 clinical staff on a thoracic ward were asked to evaluate
Thopaz in a structured format. Staff responses graded their satisfaction on a scale of Excellent, Very good,
Good, Satisfactory, Needs Improvement, or Poor. Patients with pneumo-thoraces who had chest drains
and wall suction prior to surgery who then had Thopaz following surgery were also requested to give their
feedback.
Results
The results of the survey of clinical staff satisfaction of Thopaz are as follows:
13%
13%
20%
54%
Excellent
V. Good
Good
Satisfactory
Could be improved
Poor
Figure 1: Assessment on the instructions for use of Thopaz.
100
75
6%
6%
20%
27%
34%
50
34%
48%
40%
40%
25
0
20%
27%
6%
Vacuum
Setup
34%
6%
6%
Air Flow
Rate
20%
6%
Graphic Display
Legibility
Figure 2: Assessment on the functionality of Thopaz.
20%
Alarm
System
Excellent
V. Good
Good
Satisfactory
Could be improved
Poor
13
100
75
14
27%
27%
40%
50
25
40%
0
20%
Tubing
46%
27%
Canister
53%
20%
Excellent
V. Good
Good
Satisfactory
Could be improved
Poor
Changing
Disposables
Figure 3: Assessment on using the disposables of Thopaz.
13%
87%
Excellent
V. Good
Good
Satisfactory
Could be improved
Poor
Figure 4: Overall assessment of Thopaz experience.
Additional, subjective feedback from patients was that they liked the light, compact design, and the
quietness compared to the sound of bubbling. Clinical feedback was that they liked the mobilisation
of the patients and scientific removal of chest drain.
Conclusions
l Thopaz was found to be user friendly and liked by staff and patients.
l Additional clinical benefits cited were objective decision making on when to remove the chest tube,
improved patient mobilisation and therefore physiotherapy, a reduction in use of x-rays, and improved
infection control due to reduced risk of spillages.
The benefits of digital air leak assessment after pulmonary
resection: Prospective and comparative study
J. M. Mier, L. Molins, J. J. Fibla
Cirugía Española. (2010). 87(6):385–389
15
Study Background & Design
With traditional systems, the grading of air leaks still relies on the measurement of “bubbles in a chamber”,
a method inherently prone to subjective interpretation and observer variability. To this end a prospective,
consecutive and comparative study was performed to evaluate the efficacy of digital devices (Thopaz and the
now defunct DigiVent) in measuring the postoperative air leak compared to a traditional device and how this
impacts upon the decision to withdraw chest tubes after lung resection. A total of 75 patients who underwent
elective pulmonary resection were equally divided into the three groups. There was no significant difference
between the groups regarding demographics or respiratory function. Negative pressure set on the systems
was -15 cmH2O from the closure of the chest wall muscle to the time when the drain was removed. The chest
drain was removed when < 10 ml/min for digital devices and no bubbles for the traditional system was
maintained for 12 h. Pleural effusion needed to be below 200 ml in 24 h.
Results
Chest tube removal occurred earlier for Thopaz than occurred for DigiVent and the traditional system.
5
4
4.5
3
3.3
2.4
2
Traditional System
DigiVent
Thopaz
Figure 1: The length of drainage in days for a Traditional Chest Drain,
DigiVent and Thopaz.
The standard deviation for the traditional system was far greater than occurs for either DigiVent or
Thopaz, demonstrating that inter-observer differences were reduced when using digital devices.
4
16
3.6
3
2
1
1.0
1.0
0
Traditional System
DigiVent
Thopaz
Figure 2: The standard deviation for length of drainage in days for a Traditional
Chest Drain, DigiVent and Thopaz.
Additional, subjective feedback was that patients and nurses were more comfortable with digital devices,
whilst the surgeons felt they obtained more objective information.
Conclusions
l The digital and continuous measurement of air leak instead of the currently used traditional systems reduced
the chest tube withdrawal and hospital stay by more accurately and reproducibly measuring air leak.
l The Thopaz alarm mechanism is very useful and the integrated suction provides significant independence
to the patient.
l It is possible to remove the drain significantly earlier in patients with Thopaz. Had the sample size been larger,
the result might have been even more conclusive.
l Study limitations were that the sample size was small and the lack of randomised groups.
Postoperative chest tube management: measuring air leak using
an electronic device decreases variability in the clinical practice
G. Varela, M.F. Jimenez, N.M. Novoa, J.L. Aranda
European Journal of Cardio-thoracic Surgery. (2009). 35:28—31
17
Study Background & Design
The aim of this study was to measure inter-observer variability and its impact upon deciding when to
withdraw chest tubes after lung resection and to evaluate if the use of an electronic device to measure
postoperative air leak decreased variations in clinical practice. In a prospective randomized study, 61 patients undergoing pulmonary resection were randomly assigned to either the digital group (using the now
defunct DigiVent chest drain) or the traditional group (on standard water seal). Having established the
chest tube withdrawal criteria, two thoracic surgeons with comparable clinical experience independently
evaluated whether to withdraw the chest tube. Each was blinded to the decision of their counterpart.
Fifty-four observations were recorded in the traditional group and 67 observations were recorded in the
digital group. The inter-observer variability and kappa coefficient were calculated.
Results
The inter-observer variability on when to remove the chest tube is much greater for the Traditional System
when compared to the Digital System.
Digital System
Observer 2 decision
to remove chest tube
Observation 1 Decision to Remove Chest Tube
Yes
No
Yes
32
3
No
1
31
Traditional System
Observer 2 decision
to remove chest tube
Observation 1 Decision to Remove Chest Tube
Yes
No
Yes
22
12
No
5
15
Figure 1: Showing the inter-observer variability for the Traditional and Digital Systems.
The Kappa Coefficient shows poor agreement between observers for the Traditional System and
good agreement for the Digital System.
1.0
18
0.8
0.88
0.6
0.4
0.37
0.2
Traditional System
Digital System
Figure 2: Kappa Coefficient showing agreement between clinical decisions on
whether to remove the chest tube for the Traditional System and Digital System.
A low Kappa Coefficient suggests poor agreement between observers, whereas
a high Kappa Coefficient suggests good agreement between observers.
Conclusion
l There was a high rate of disagreement as to when to remove chest tube after lung resection for the
traditional water seal system, and a high rate of agreement when an electronic device with a digital air
flow meter was used.
The quantification of postoperative air leak.
Cerfolio R.J., Bryant A.S. (2009). Multimedia Manual of Cardiothoracic Surgery.
DOI:10.1510/mmcts.2007.003129. Open access article available online.
19
Study Background & Design
Air leaks are the most frequent cause of prolonged hospital stay, increased cost and patient dissatisfaction.
The management of chest tubes in patients with air leaks is optimized when the air leak is scientifically
evaluated. To eliminate subjectivity, companies have developed digital pleural drainage systems that are
able to quantify the size of air leaks in ml/min. In this study, 98 patients undergoing elective pulmonary
resection were recruited, 48 into the Thopaz group and 50 into the traditional system group. Patient age,
body mass index, pulmonary function tests and types of procedures were similar in both groups.
Results
Comparison shows that patients on Thopaz have a significantly reduced duration of chest drainage than
those on the Traditional System. There was a reduction in length of hospital stay for the Thopaz group,
however this did not reach significance.
5
4
4.4
4.6
3.9
3
3.0
Days of drainage
(p=0.04)
Days in hospital
(p=0.15)
2
Traditional System
Thopaz
Figure 1: Showing a comparison between a Traditional System and Thopaz in the duration of chest
drainage, and length of hospital stay.
Comparison shows that pneumothorax patients on Thopaz have a significantly reduced length of hospital
stay than those on the Traditional System.
7
20
6.5
6
3.9
5.4
5
Days in hospital
(p=0.03)
4
Traditional System
Thopaz
Figure 2: Showing a comparison between a Traditional System and Thopaz in the length of hospital
stay for pneumothorax patients.
Conclusion
l Treatment of air leaks has evolved to improved chest tube management through the use of scientific
measures, leading to the earlier removal of chest tubes, decreased pain and morbidity and the early
discharge of patients.
l There is little question that digital air leak devices are the future of the bedside management of air leaks.
l Further studies are needed to determine their efficacy on all patients requiring drainage, and to determine
costs savings.
21
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